Ultrasonic endovascular catheter

ABSTRACT

An apparatus for performing an endovascular procedure. The apparatus includes an ultrasonic catheter supporting a first inflatable balloon. The apparatus includes an ultrasonic wave guide associated with the ultrasonic catheter. The ultrasonic wave guide includes a fluid lumen. The ultrasonic wave guide has a proximal portion and a distal portion. The apparatus includes an ultrasonic transducer having a transducer horn. The proximal portion of the ultrasonic wave guide is crimped directly onto the transducer horn. The ultrasonic transducer is configured to vibrate the ultrasonic wave guide at an ultrasonic frequency, and the ultrasonic wave guide is configured to transmit the ultrasonic frequency from the ultrasonic transducer to the distal portion.

TECHNICAL FIELD

This document relates generally to the art of endovascular proceduresand, more particularly, to an endovascular catheter using ultrasonicenergy to perform a medical procedure, such as an atherectomy orthrombectomy.

BACKGROUND

Ultrasonic catheters have been proposed. An example of such a catheteris shown in U.S. Pat. No. 7,540,852, the disclosure of which is fullyincorporated herein by reference. While this catheter achieves thedesired result of providing enhanced disruption of blood vesselobstructions, the present disclosure proposes certain modifications orimprovements to enhance the results achieved during an endovascularprocedure in terms of clearing an obstruction from a vessel (such as,for example, an atherectomy for removing atherosclerosis from a bloodvessel or or a thrombectomy for dissolving a thrombus or embolus).

SUMMARY

Summarizing the disclosure, an improved ultrasonic catheter forenhancing an endovascular procedure, such as an atherectomy orthrombectomy. The catheter may include a wave guide for transmittingultrasonic energy from a transducer, and which is also rotated by amotor to facilitate enhanced disruption of the concerned obstruction ina transverse direction. Embodiments of waveguide include distal anchorsthat help prevent movement of the distal end, and may also include adeployable filter that may open distal of the obstruction to capture anydislodged debris (which may be suctioned out through a lumen in anassociated catheter body).

To help improve the treatment regimen, an ultrasonic catheter may alsobe provided with barriers, such as inflatable balloons, to cordon off atreatment site. In any embodiment including one or more balloons, thewaveguide may serve the dual purposes of inflating the balloon(s), aswell as transmitting ultrasonic energy to an obstruction. To furtherenhance the energy transmission for treatment purposes, a portion of theultrasonic catheter may include one or more curves (possibly selectivelyactuated by way of a remote control) in order to space an exposedportion of the wave guide away from the catheter body to thereby enhancethe vibratory action provided.

According to a first specific aspect of the disclosure, an apparatus forperforming an endovascular procedure is provided. The apparatuscomprises a catheter and an associated wave guide having a distal endportion adapted for extending from the lumen of the catheter. Anactuator for vibrating and rotating the wave guide is also provided.

In one embodiment, the actuator comprises an ultrasonic transducer forvibrating the wave guide and a motor for rotating the ultrasonictransducer or the wave guide. The catheter may include a lumen forreceiving a proximal portion of the wave guide, which may include adistal portion having at least one curve or bend. A connector connectedto the catheter may at least partially include the actuator, and acontroller may be provided for controlling the amount and direction ofrotation of the wave guide.

According to a further aspect of the disclosure, an apparatus forperforming an endovascular procedure comprises a catheter and a waveguide associated with the catheter. The wave guide includes a distal endwith an anchor for anchoring the wave guide. An actuator is alsoprovided for vibrating the wave guide.

In one embodiment, the anchor comprises a centering coil. In anotherembodiment, the anchor comprises one or more weights. In still anotherembodiment, the anchor comprises an anchoring cone, and in another is aninflatable balloon. The wave guide may comprise a wire.

Still a further aspect of the disclosure pertains to an apparatus forperforming an endovascular procedure. The apparatus comprises a catheterand a wave guide associated with the catheter. The wave guide includes adistal end having a filter with an open end facing a proximal end of thewave guide. An actuator is also provided for vibrating the wave guide.

In one embodiment, the filter comprises a deployable frame supporting aflexible material. The deployable frame may comprise a shape memorymaterial. The flexible material may comprise a porous mesh or similarmaterial for performing a filtering function.

Yet a further aspect of the disclosure pertains to an apparatus forperforming an endovascular procedure. The apparatus comprises a catheterincluding a lumen and supporting a first inflatable balloon. A waveguide includes a distal end portion projecting from the lumen proximallyof the first inflatable balloon. An actuator is provided for actuatingthe wave guide.

In one embodiment, the wave guide comprises a tube for supplyinginflation fluid to the first balloon. The apparatus may further includea second balloon, and the wave guide may comprise a wire extendingbetween the first and second balloons. A portion of the catheter betweenthe first and second balloons may comprise one or more openings fortransmitting fluid to or from a portion of a vessel bounded by the firstand second balloons when inflated.

Another aspect of the disclosure pertains to an apparatus for performingan endovascular procedure. The apparatus comprises a catheter includinga lumen extending along a proximal end portion and a distal end portion.A wave guide includes a first portion positioned within the lumen, asecond exposed portion, and a third portion connected to the distal endportion of the catheter. An actuator is provided for vibrating at leastthe second exposed portion of the wave guide.

In a further aspect, the disclosure pertains to an apparatus forperforming an endovascular procedure. The apparatus comprises a catheterincluding a proximal end portion including a lumen and opposed portions.A wave guide includes a first portion positioned within the lumen and asecond exposed portion positioned along the opposed portions of thecatheter.

In one embodiment, an actuator is provided for vibrating the wave guide.The catheter may also include opposed curved portions. The wave guidemay be positioned in a gap or space between the opposed curved portions,which may surround the wave guide (e.g., core wire or tube).

Yet another aspect of the disclosure pertains to an apparatus forperforming an endovascular procedure. A catheter supports a firstinflatable balloon. A wave guide is associated with the catheter andincludes a lumen. An actuator, such as an ultrasonic transducer, isprovided for coupling to a proximal end of the wave guide.

In one embodiment, the apparatus further includes a second inflatableballoon supported by the tube proximally of the first inflatableballoon. A tip may also be provided for sealing a distal end of thetube. The tip may include a guidewire lumen.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The accompanying drawing figures incorporated herein and forming a partof the specification, illustrate several aspects of the ultrasonicendovascular catheter and, together with the description, serve toexplain certain principles thereof. In the drawing figures:

FIG. 1 is a schematic view of a prior art catheter system including anultrasonic catheter;

FIG. 2 is a side view illustrating a general layout of a prior artcatheter;

FIG. 3 is a partially cross-sectional, partially cutaway view of acatheter including an ultrasonic wave guide;

FIG. 4 is a partially cutaway, schematic view illustrating an actuatorfor both vibrating and rotating the wave guide;

FIGS. 5 and 6 are views illustrating the wave guide including differentcurved portions for moving in the transverse direction to enhance thetreatment provided in terms of dissolving an obstruction in a vesselreceiving the wave guide;

FIGS. 7, 8, and 9 are side views illustrating various anchors placed ata distal end portion of an ultrasonic wave guide;

FIGS. 10, 11, and 12 are side views of various filters placed at adistal end portion of an ultrasonic wave guide;

FIGS. 13, 14 and 15 illustrate an embodiment of an ultrasonic catheterincluding first and second inflatable balloons for isolating a treatmentsite to be treated by an exposed portion of a wave guide;

FIGS. 16 and 17 schematically illustrated another ultrasonic catheterincluding a tube that may transmit ultrasonic energy and also serve toinflate one or more associated balloons; and

FIG. 18 illustrates still a further embodiment of an ultrasonic catheterincluding a plurality of curved portions spaced from a wave guide fortransmitting energy to a treatment site.

Reference will now be made in detail to the presently disclosedembodiments of the inventive aspects of the ultrasonic endovascularcatheter, examples of which are illustrated in the accompanying drawingfigures.

DETAILED DESCRIPTION

Ultrasound or ultrasonic catheters provide for disruption of occlusionsin blood vessels, such as for example, plaques, clots, lesions, or likeobjects that hinder blood flow. Catheters generally include a catheterbody (shaft), an ultrasonic energy transmission member disposed withinthe catheter body and a distal head coupled with the energy transmissionmember and disposed at or near the distal end of the catheter body. Theultrasonic wave guide transmits ultrasonic energy from an ultrasonictransducer to the distal end of the catheter, causing it to vibrate and,thus, disrupt dissolve, or debulk vascular occlusions (which proceduresare generally called atherectomies or thrombectomies). A number ofimproved features of such an ultrasonic catheter are outlined more fullyin the following description.

Referring now to FIG. 1, one embodiment of an ultrasonic catheter system20 includes an ultrasound or ultrasonic catheter 10 and an energy source16 (which may comprise an ultrasonic generator). Catheter 10 includes adistal end 26 for disrupting occlusions, a catheter shaft or body 27,and a proximal connector 12 for coupling catheter 10 with an ultrasonictransducer 14. Ultrasonic transducer 14 is coupled with source 16 via aconnector 28, and generator is coupled with a control, such as afoot-actuated on/off switch 18 via another connector 29. Source 16provides energy to transducer 14 and, thus, to ultrasonic catheter 10.

Catheter 10 further includes an ultrasonic wave guide (or “corewire”—not shown in FIG. 1) that extends through the catheter body 27 andtransmits energy from the transducer 14 to the distal end 26. Someembodiments of catheter 10 include a guidewire, which in FIG. 1 is shownas a so-called “rapid exchange” guidewire 13 and guidewire port, whileother embodiments include a proximal guidewire port for over the wireguidewire delivery. In some embodiments, transducer 14 further includesa coupler 15 for coupling the catheter 10 to transducer 14. Connectors28, 29 may comprise an electric cord or cable or any other suitableconnecting devices for coupling on/off switch 18, source 16 andtransducer 14. In an alternative embodiment, on/off switch 18 is locatedon source 16.

In addition to proximal connector 12, ultrasonic catheter 10 may includeone or more other various components, such as a Y-connector 11 includinga fluid inlet port 17 (or aperture) for passage of irrigation fluid.Inlet port 17 may be removably coupled with an irrigation tube 24, whichin one embodiment may be coupled with a fluid refrigerator 30. Therefrigerator 30 may, in turn, be coupled with a fluid container 32 via aconnector tube 34. This arrangement may be used for introducing one ormore fluids into catheter 10. Fluid may be used to cool any part of thedevice, such as the ultrasonic wave guide, thus helping reduce wear andtear on the catheter 10. In some embodiments, fluid inlet port 17 islocated farther proximally on proximal connector 12, to allow fluid tobe applied within connector 12. In some embodiments, refrigerated fluidis used, while in other embodiments irrigation fluid may be kept at roomtemperature. In various embodiments, oxygen supersaturated fluid,lubricious fluid, or any other suitable fluid or combination of fluidsmay be used, and again, such fluids may be refrigerated or kept roomtemperature. In an alternative embodiment to that shown in FIG. 1,refrigerator 30 and fluid container 32 are combined in one unit.

Generally, catheter 10 may include any suitable number of side-arms orports for passage of a guidewire, application of suction, infusingand/or withdrawing irrigation fluid, dye and/or the like, or any othersuitable ports or connections. Also, ultrasonic catheters 10 per thedisclosure may be used with any suitable proximal devices, such as anysuitable ultrasonic transducer 14, energy source 16, coupling device(s)and/or the like. Therefore, the exemplary embodiment shown in FIG. 1 andany following descriptions of proximal apparatus or systems for use withultrasonic catheters 10 should not be interpreted to limit the scope ofthe appended claims.

Referring now to FIG. 2, an enlarged view of catheter 10 is shown.Proximal connector 12, Y-connector 11, inlet port 17, catheter body 27,distal end 26 and guidewire 13 are all shown. Catheter body 27 isgenerally a flexible, tubular, elongate member, having any suitablediameter and length for reaching a vascular occlusion for treatment. Inone embodiment, for example, catheter body 27 preferably has an outerdiameter of between about 0.5 mm and about 5.0 mm. In other embodiments,as in catheters intended for use in relatively small vessels, catheterbody 27 may have an outer diameter of between about 0.25 mm and about2.5 mm. Catheter body 27 may also have any suitable length. As discussedbriefly above, for example, some ultrasonic catheters have a length inthe range of about 150 cm. However, any other suitable length may beused without departing from the scope of the present disclosure.

Referring now to FIG. 3, a proximal portion of one embodiment of anultrasonic catheter 110 is shown in cross-section. An ultrasonic waveguide 140 extends from a sonic connector 152 distally to a distal end(not shown) of catheter 110. A catheter body 127 of catheter 110 isshown only in part, whereas catheter body typically extends distally to(or near) the distal end of catheter 110, with the wave guide 140 alsoextending a particularly long distance (e.g., 30 centimeters or greater,and typically between about 15 centimeters and 30 centimeters). Thecatheter body 127 may be a constant diameter, or may have a variablediameter from the proximal to the distal end (such as, for example,wider in diameter at the proximal end near the point of entering thevasculature than at the distal end, where the vessel is narrower)

Catheter 110 also includes a proximal housing 112 (or “proximalconnector”), having an inner bore 144 (or “inner cavity”) in which sonicconnector 152, a portion of ultrasonic wave guide 140 and one or morevibration absorbers 150 reside. Housing 112 is coupled with aY-connector 111, which includes a fluid inlet port 117 (or aperture),and Y-connector 111 is coupled with catheter body 127.

In various embodiments, housing 112 may suitably include one or moresurface features 142 for increasing the overall surface area of theouter surface of housing 112. Increased surface area enhances theability of housing 112 to dissipate heat generated by ultrasonic waveguide 140 out of catheter 110. Surface features 142 may have anysuitable size or shape, such as ridges, jags, undulations, grooves orthe like, and any suitable number of surface features 142 may be used.Additionally, housing 112 may be made of one or more heat dissipatingmaterials, such as aluminum, stainless steel, any other conductivemetal(s), or any suitable non-metallic conductive material(s).

In most embodiments, ultrasonic wave guide 140, such as wire, extendslongitudinally through a lumen of catheter body 127 to transmitultrasonic energy from an ultrasonic transducer 14 (not shown in FIGS. 2and 3), connected to the proximal end of proximal housing 112, to thedistal end of catheter 110. Wave guide 140 may be formed of any materialcapable of effectively transmitting ultrasonic energy from theultrasonic transducer 14 to the distal end of catheter body 127,including but not limited to metals such as pure titanium or aluminum,titanium or aluminum alloys, or shape memory materials (such asnitinol), and may be coated (such as using a polymeric material). Again,additional details of ultrasonic wave guides 140 may be found in thepatent applications incorporated by reference. Similarly, reference maybe made to the incorporated patent applications for descriptions ofhousing 112, sonic connector 152, vibration absorbers 150, Y-connector111 and the like. For example, housing 112 and other features aredescribed in detail in Ser. No. 10/722,209, filed Nov. 24, 2003,entitled “Steerable Ultrasound Catheter,” incorporated herein byreference.

Ultrasonic wave guide 140 typically passes from a sonic connector 152,through bore 144 and Y-connector 111, and then through catheter body127. Fluid inlet port 117 is in fluid communication with a lumen inY-connector, which is in fluid communication with a lumen extendingthrough catheter body 127. Thus, fluid introduced into fluid inlet port117 is typically free to flow into and through catheter body 127 tocontact ultrasonic wave guide 140. Fluid may flow out of catheter body127 through apertures in the distal head (not shown) or through anyother suitable apertures or openings, such as apertures located incatheter body 127 itself. Any suitable fluid may be passed through fluidinlet port 117 and catheter body 127, such as refrigerated fluid,lubricious fluid, super-saturated saline or contrast/saline mixture, orthe like. Cooling and/or lubricating ultrasonic wave guide 140 mayreduce friction and/or wear and tear of ultrasonic wave guide 140, thusprolonging the useful life of ultrasonic catheter 110 and enhancing itsperformance.

Referring now to FIG. 4, the wave guide 140 or wire may employ anactuator that both vibrates the wave guide through the application ofultrasonic energy, such as from transducer 14, and also causes it torotate about its longitudinal axis X, such as through the applicationfor rotational motion to the transducer or any structure connected tothe wave guide. In one embodiment, this may be achieved by providing anintegral, rotary motor 154 as part of the ultrasonic transducer 14(which may include the sonic connector 152 therein, or the wave guide140 may be crimped directly onto the horn of the transducer). Power forthe motor 154 may be supplied by a pair of wires 156, 158 (one toground, one to positive) for causing relative rotation of the wave guide140. Wires 156, 158 may be connected to an energy source, such as apower supply 160 for powering both the motor 154 and the transducer 14(but separate sources could be used, including for example, integralbatteries to avoid the need for external wires).

As illustrated, the wires 156, 158 if present may be twisted to allowfor the relative rotation without creating binding problems. Therotation of the wave guide 140 may be continuous in one direction, ormay be bi-directional (including a rotation of less than 360 degrees ineach direction, such that the wave guide may be caused to oscillateabout the longitudinal axis X). Control of the rotation may be providedby an associated controller 159 for controlling the power supply 160,which may reverse the flow of current to the motor 154 according to apre-programmed operation or as a result of manual control provided by aclinician to control the relative direction and amount of rotation.Using the controller 159, the rotation may also be selectively turned onand off, while the vibratory energy is on, or the rotation may beprovided while the vibratory energy is turned off.

As indicated in FIGS. 5 and 6, the wave guide 140 may also be providedwith a curved portion C, which may include a single curve (FIG. 5) ormultiple curves (FIG. 6). The curved portions C extend in the transversedirection T and thus are spaced from the axis X. Thus, causing the waveguide 140 to rotate (arrow R) using motor 154 or otherwise rotating itvia an imparted external force, creates movement in the transversedirection T. Combined with the vibration created by the ultrasonicenergy transmitted from transducer 14, the wave guide 140 may thus serveto engage and clear an obstruction, such as a plaque, lesion orthrombus/embolus, when positioned in a blood vessel and associated withconnector 112 of catheter 110. The catheter body 127 may also beadvanced in the vessel and suction applied (such as through port 117) toaspirate any dislodged material (which may be done using a two parttelescoping catheter body, such that one part remains connected toconnector 112 and another part advances and retracts relative to theconnected part).

Turning now to FIGS. 7-9, a further aspect of the disclosure isillustrated in several embodiments. In these embodiments, the wave guide140 is provided with an anchor 180 at a distal end thereof, which mayinclude a tip 141. This anchor serves to hold the distal end of the waveguide at a centered location within the vessel, and preclude it frommoving in a transverse direction T.

In the FIG. 7 embodiment, the anchor 180 is shown as including a coil182 having a radial extent that is substantially greater than thediameter of the wave guide 140 for engaging the interior walls of theblood vessel. The coil 182 may have a single loop or multiple loops, asshown. As noted above, the wave guide 140 may also be provided with aninitially straight configuration (such as for passing into or through anobstruction, such as a thrombus), and as a result of a shape memorymaterial, be caused to assume the coiled configuration in situ as aresult of a temperature change (such as by a refrigerated fluid). Thecoil 182 may also have a conical configuration with a relatively tightcoil, and may thus function as a filter for capturing any dislodgedmaterial during the endovascular procedure.

Alternatively or additionally, the FIG. 8 embodiment shows that theanchor 180 takes the form of one or more weights 184 positionedproximally of the tip 141. These weights 184 may be in the form of balls(which may be generally spherical), and thus serve to hold the distalend of the wave guide 140, and preclude it from moving in a transversedirection T. As illustrated, the tip 141 may also optionally comprise aweight 184. The extended length of section 140 c may be controlled byadvancing or retracting catheter body 127.

For the embodiment of FIG. 9, the anchor 180 comprises an anchoring cone186, which may have circumferentially spaced radial extensions 186 a forengaging the vessel walls to provide a centering function, and againtransmitting the ultrasonic energy locally to the proximal portion 140 cof the wave guide 140. As with the FIG. 7 embodiment, the cone 186 mayalso be provided with an initially relaxed configuration for insertion,and as a result of a shape memory material, be caused to assume thedeployed configuration in situ as a result of a temperature change (suchas by a refrigerated fluid).

This embodiment further illustrates that the cross-section of the waveguide 140 may be locally increased, such as by creating a spherical ball188 therein. This helps to ensure that the wave guide 140 does notdisconnect from the anchor 180 as a result of the foreshortening andlengthening creating during the application of vibratory energy.Multiple balls 188 may also be provided, such as one distal of theanchor 180 and one proximal of the anchor. The balls 188 may begenerally spherical, and a distal ball provided at tip 141 may be madeby melting the material of the wave guide 140.

Turning now to FIGS. 10, 11 and 12, it can also be appreciated that adistal end of the wave guide 140 may be provided with a filter 190,which may be initially collapsed for passing through a thrombus B in avessel V via a soft tip 191. In the illustrated embodiment, the filter190 when expanded (such as by using a shape memory material) includes anopen proximal end 12 and a body 194 comprising a filtering material,such as a fine mesh, cage, or the like. Thus, when the wave guide 140 isultrasonically vibrated, any particles loosened from the obstruction(e.g., thrombus B) as a result may travel distally through the open endof the filter 190 and be captured by the body 194 for later removal oncethe procedure is completed. To remove any captured particles or objects,the filter 190 may be collapsed, such as using an external sheath 193(which may also provide suction via a provided port to withdraw anydislodged material).

FIGS. 11 and 12 illustrate a specific example of a filter 190, which maycomprise a body 194 including an expandable frame 196 (again, using ashape memory material) supporting a flexible or foldable material 198,such as a fabric, film (such as, for example, a porous polymer film), orthe like. The frame 196 when expanded may form a conical structurehaving an open proximal end 192 oriented similarly as in FIG. 10 and aclosed distal end. The material 198 connected to the frame forms abasket for capturing dislodged particles created from the vibration ofthe wave guide 140. As illustrated, the filter 190 may be connected tothe wave guide 140 by tethers 196 a, which may also form part of theframe 196, and thus the wave guide may also transmit vibratory energy tothe filter 190. To remove any captured particles or objects, the filter190 may be collapsed, such as by using temperature control to return theshape memory material to its original state during insertion.

A further embodiment of an ultrasonic catheter 200 is illustrated withreference to FIGS. 13 and 14. In this embodiment, the catheter body 127supports a plurality of inflatable balloons. Specifically, a firstballoon 202 is positioned adjacent a distal end of the body 127, and asecond balloon 204 is positioned proximally of the first balloon. Theballoons 202, 204 may be inflated via a dual or coaxial inflation lumen128 provided in the catheter body 127, which may include inlets 128 alocated in and communicating with the interior compartment of eachballoon. Lumen 128 may receive inflation fluid from the fluid inlet port117. When inflated, the balloons 202, 204 thus serve to anchor thecatheter 200 at a treatment site, and also isolate a portion of the sitefor undergoing treatment.

The catheter body 127 may also include a second lumen 129 for receivingthe wave guide 140. This second lumen 129 allows for an exposed portionto exit and pass external to the body 127 along a distal portionthereof, and ultimately re-enter the body at a point distal of the exitpoint, but proximal of the first distal balloon 202. To avoidinterfering with the ultrasonic vibration of the wave guide 140, acorresponding portion 127 a of the catheter body 127 may be non-linearor curved, and thus spaced from the wave guide 140, but could optionallybe straight or partially curved.

A third lumen 130 in the body 127 may communicate with openings 130 a inthe portion 127 a of the catheter body 127 intermediate the balloons202, 204. These openings 130 a may be used to withdraw fluid from avessel when the body 127 is inserted therein, such as through a fluidport 118 associated with the connector 112. Alternatively, the openings130 a via lumen 130 or may be used to deliver substances to the vessel,such as, for instance, thrombolytic agents (such as, for example,Eminase (anistreplase) Retavase (reteplase) Streptase (streptokinase,kabikinase) t-PA (class of drugs that includes Activase) TNKase(tenecteplase) Abbokinase, Kinlytic (rokinase), or others). The body 127may also optionally include a guidewire lumen 131 for receiving aguidewire 13, but use of a rapid-exchange configuration as describedabove is also possible.

In use, the wave guide 140 as a result of the advancement of thecatheter body 127 may pass through or adjacent the obstruction in avessel, such as thrombus B. The balloons 202, 204 may be inflated in thevessel being treated to concurrently anchor the catheter 200, which ascan be appreciated serves to isolate a portion of the vessel includingthe obstruction (thrombus B). Substances such as thrombolytic agents maythen be optionally delivered to the isolated portion of the vessel undertreatment via port 118, lumen 130, and openings 130 a to aid indissolving the obstruction, and concurrently (or not), the wave guide140 may be used to deliver ultrasonic energy to further assist inclearing the obstruction.

With the balloons 202, 204 remaining inflated, it can also beappreciated that the openings 130 a may be used to remove material(including fluid) from the isolated portion of the vessel, such as byapplying appropriate suction to the port 118. This may be done after asuitable amount of time has passed to ensure that any agents introducedhave had time to act on the obstruction. When the obstruction is reducedor removed, the balloons 202, 204 may be deflated and the catheter body127 moved along guidewire 13 as desired for removal or further treatmentat an alternate location.

A further embodiment of an ultrasonic catheter 300 is shown in FIGS. 16and 17, which includes a catheter body 127. In FIG. 16, the wave guide140 comprises a tube 302, rather than a solid wire. This tube 302 whichmay be used to transmit ultrasonic energy from a transducer 14 to anobstruction, such as thrombus B (or thrombi). The distal end 302 a ofthe tube 302 serving as wave guide 140 may be capped by an atraumatictip 304, which may be used to move the tube 302 through the thrombus B(or thrombi). The tip 304 may also include a guidewire lumen 304 a forguiding the tube 302 along a guide wire (not shown), which may beassociated with a lumen in the catheter body 127 (see, e.g., FIG. 14).

In one particular embodiment, the tube 302 is adapted to inflate aballoon 306. The balloon 306 may be supported on the tube 302 proximallyof the tip 304. The inflation fluid for inflating the balloon 306 mayflow through the tube 302 via a proximal port (not shown). The fluid mayexit the tube 302 to the interior compartment of the balloon via a port302 b.

In use, the catheter 300 may be partially passed through the obstruction(thrombus or thrombi) using tip 304 to extend the tube 302 therethrough,and the balloon 306 inflated. The transducer 14 may be activated totransmit energy to the obstruction to disrupt or dislodge it, with anydislodged particles or material being aspirated through the catheterbody 127 (see arrows A). Additionally or alternatively, any thrombolyticagents may be delivered via the catheter body 127 to the treatment siteprior to or during the tube activation to facilitate dissolving theobstruction, with any such substances remaining at the introduction sitein view of the distal blockage created when the balloon 306 is inflated.When the procedure is complete, the balloon 306 may be deflated usingthe port 302 b, and the catheter 300 moved accordingly.

FIG. 17 further illustrates that a second, proximal balloon 308 may alsobe provided on the ultrasonic catheter 300, which may likewise beinflated using a port 302 c in tube 302 (such as using a coaxial or duallumen). The balloons 306, 308 may thus be inflated on either side of theobstruction to isolate it. Wave guide 140 may be activated as desired todisrupt the obstruction. Ports or openings 302d may also be provided inthe tube 302 for aspirating debris or introducing treatment agents, withcorresponding lumens (not shown) provided in the tube as necessary forthis purpose (see, e.g., multi-lumen catheter body 127 in FIG. 14).Alternatively, once the obstruction is cleared, the proximal balloon 308may be deflated and the body 127 used to aspirate any dislodgedmaterial.

Turning now to FIG. 18, a further embodiment of an ultrasonic catheter500 is shown. In this embodiment, the catheter body 127 may include oneor more curved portions, such as two curved portions 127 a, that arespaced in a transverse direction T from the wave guide 140. In theillustrated embodiment, the portions 127 a are symmetrical about thelongitudinal axis X and curved in opposition to each other (relative toa central longitudinal axis of the catheter). These portions 127 thusprovide a centering function for the wave guide 140, which may beexposed in a space between the portions 127 a for transmittingultrasonic energy from an associated transducer 14 to a treatment site.The wave guide 140 may also extend to and possibly through a distal tipof the catheter body 127, and may be connected to it.

In summary, improved ultrasonic catheters 110, 200, 300, 500 aredisclosed. In one example, the catheter 110 includes a wave guide 140for transmitting ultrasonic energy from a transducer 14, and which isalso rotated by a motor 154 to facilitate enhanced disruption of theconcerned obstruction in a transverse direction. Embodiments ofwaveguide 140 include distal anchors 180 to restrain a correspondingportion of the waveguide, and may also include a deployable filter 190that may open distal of the obstruction to capture any dislodged debris(which may be aspirated by the catheter body 127, including by advancingit). An embodiment of an ultrasonic catheter 200 is also disclosed thatincludes selectively inflatable balloons 206, 208 to cordon off atreatment site, as well as an embodiment in which the waveguide 104comprises a tube 302 that may serve the dual purposes of inflating anassociated balloon 306 (or balloons 306, 308), as well as to transmitultrasonic energy to an obstruction. Still a further embodiment of acatheter 500 comprises a plurality of curved portions 127 a spaced froma wave guide 140.

The foregoing description has been presented for purposes ofillustration. It is not intended to be exhaustive or to limit theembodiments to the precise form disclosed. Obvious modifications andvariations are possible in light of the above teachings. Allmodifications and variations are within the scope of the appended claimswhen interpreted in accordance with the breadth to which they arefairly, legally and equitably entitled.

1-25. (canceled)
 26. An apparatus for performing an endovascularprocedure, comprising: an ultrasonic catheter supporting a firstinflatable balloon; an ultrasonic wave guide associated with theultrasonic catheter, the ultrasonic wave guide including a fluid lumen,the ultrasonic wave guide having a proximal portion and a distalportion; and an ultrasonic transducer having a transducer horn, whereinthe proximal portion of the ultrasonic wave guide is crimped directlyonto the transducer horn, the ultrasonic transducer is configured tovibrate the ultrasonic wave guide at an ultrasonic frequency, theultrasonic wave guide is configured to transmit the ultrasonic frequencyfrom the ultrasonic transducer to the distal portion.
 27. The apparatusof claim 26, wherein the first inflatable balloon is connected to theultrasonic wave guide, and the ultrasonic wave guide includes a firstport for supplying an inflation fluid to the first inflatable balloonvia the fluid lumen.
 28. The apparatus of claim 27, comprising a secondinflatable balloon supported by the ultrasonic wave guide, wherein thefluid lumen is dual or coaxial, the ultrasonic wave guide includes asecond port for supplying the inflation fluid through the fluid lumen tothe second inflatable balloon, the second inflatable balloon is proximalof the first inflatable balloon.
 29. The apparatus of claim 28, furthercomprising a tip sealing a distal end of the tube.
 30. The apparatus ofclaim 29, wherein the tip includes a guidewire lumen.
 31. The apparatusof claim 28, further comprising: a second lumen in the ultrasonic waveguide, and at least one aspiration port extending through the ultrasonicwave guide to the second lumen, the second lumen and the at least oneaspiration port are configured for aspirating debris in a proximaldirection, the at least one aspiration port is located between the firstinflatable balloon and the second inflatable balloon.
 32. The apparatusof claim 26, comprising: a second lumen in the ultrasonic wave guide,and at least one aspiration port extending through the ultrasonic waveguide to the second lumen, the second lumen and the at least oneaspiration port are configured for aspirating debris in a proximaldirection.
 33. The apparatus of claim 26, comprising: an ultrasonicgenerator coupled to the ultrasonic transducer; and a switch coupled tothe ultrasonic generator, wherein the ultrasonic generator is configuredto provide electricity to the ultrasonic transducer, the ultrasonictransducer is configured to apply the ultrasonic frequency to theultrasonic wave guide.
 34. The apparatus of claim 33, wherein theultrasonic wave guide has a crimped connection where the proximalportion is crimped directly onto the transducer horn, the ultrasonicwave guide is configured to vibrate from the proximal portion at thecrimped connection to the distal portion of the ultrasonic wave guide.35. An apparatus for performing an endovascular procedure, comprising: afirst balloon; an ultrasonic wave guide having a proximal end and adistal end, the ultrasonic wave guide is a wire having an exposedportion, the ultrasonic wave guide is configured to transmit ultrasonicenergy from the proximal end to the distal end, and an ultrasoniccatheter supporting the first balloon and having a first lumen and asecond lumen, the first lumen being configured for transmitting aninflation fluid to or from the first balloon, the second lumen beingconfigured for receiving the ultrasonic wave guide, the second lumenhaving an exit point and a re-entry point, wherein the ultrasonic waveguide exits the second lumen at the exit point and re-enters the secondlumen at the re-entry point, wherein the exposed portion of theultrasonic wave guide lies between the exit point and the re-entry pointof the second lumen.
 36. The apparatus of claim 35, wherein theultrasonic catheter has an intermediate portion and the first balloon isdistal to the exposed portion of the ultrasonic wave guide and theintermediate portion of the ultrasonic catheter, the intermediateportion includes a straight portion.
 37. The apparatus of claim 35,wherein the ultrasonic catheter supports a second balloon, wherein thefirst lumen is dual or coaxial, the first lumen is configured fortransmission of the inflation fluid to or from the first balloon and thesecond balloon.
 38. The apparatus of claim 35, further comprising asecond balloon, wherein the ultrasonic catheter supports the secondballoon, wherein the exposed portion of the ultrasonic wave guide isbetween the first and second balloons.
 39. The apparatus of claim 38,wherein the first and second balloons are configured to anchor theultrasonic catheter at a treatment site, wherein the ultrasonic catheterincludes an intermediate portion being spaced from the ultrasonic waveguide, wherein the ultrasonic catheter further comprises a third lumenhaving openings in the intermediate portion.
 40. The apparatus of claim35, wherein the ultrasonic catheter includes an intermediate portion,the intermediate portion being spaced from the ultrasonic wave guide.41. The apparatus of claim 40, wherein the ultrasonic catheter furthercomprises a third lumen having openings in the intermediate portion. 42.An ultrasonic catheter for performing an endovascular procedure,comprising: a catheter body having a first lumen, the catheter bodyhaving a catheter body distal end; an ultrasonic wave guide having afluid lumen extending through the ultrasonic wave guide, the ultrasonicwave guide having a proximal portion and a distal portion, the proximalportion having a proximal end, the distal portion having a distal end;and a first inflatable balloon coupled to the distal portion of theultrasonic wave guide, the first inflatable balloon being in fluidcommunication with the fluid lumen via a port, wherein the ultrasonicwave guide is configured to extend through the first lumen of theultrasonic catheter, the ultrasonic wave guide is configured to extenddistally beyond the catheter body distal end, the ultrasonic wave guideis configured to receive ultrasonic energy at the proximal portion, theultrasonic wave guide is configured to transmit ultrasonic energy fromthe proximal portion to the distal end to disrupt or displace anocclusion in a vascular region, the ultrasonic wave guide is configuredto inflate and to deflate the first inflatable balloon via the fluidlumen and port.
 43. The apparatus of claim 42, further comprising anultrasonic transducer having a transducer horn, wherein the proximalportion of the ultrasonic wave guide is crimped directly onto thetransducer horn, the ultrasonic transducer is configured to vibrate theultrasonic wave guide at an ultrasonic frequency.
 44. The apparatus ofclaim 42, wherein the ultrasonic wave guide comprises an exposedportion, the first inflatable balloon is coupled to the exposed portionof the ultrasonic wave guide, the first inflatable balloon is configuredto anchor the ultrasonic catheter at a treatment site.
 45. The apparatusof claim 42, further comprising: a second lumen in the catheter body;and a tip sealing the fluid lumen at the distal end of the ultrasonicwave guide, wherein the tip includes a guide wire lumen, the guide wirelumen and the second lumen of the catheter body are configured toreceive a guide wire.